Browse > Article
http://dx.doi.org/10.15324/kjcls.2020.52.2.91

Six Sigma Analysis of Vitamin D Measurement Using External Quality Assessment Program  

Ji, Myungsuk (Department of Laboratory Medicine, Kangbuk Samsung Hospital)
Publication Information
Korean Journal of Clinical Laboratory Science / v.52, no.2, 2020 , pp. 91-97 More about this Journal
Abstract
Standardization of vitamin analysis continues around the world, and much effort has been made to improve the accuracy of the results. This study analyzed the sigma metrics of the vitamin D test using the external quality assessment (EQA) program. Sigma metrics is used for quantitative tests performed in the laboratory, and the test results can be objectively visualized in terms of quality. This analysis was performed based on the accuracy of the College of American Pathologists (CAP) using the results of the 2019 accuracy-based vitamin D (ABVD) survey, and about 300 laboratories participated in the survey. Reference values were obtained by the Center for Disease Control and Prevention (CDC) reference laboratory. At six different concentrations, the sigma metrics were analyzed to be 1.00, 1.85, 2.42, 1.01, 1.54 and 0.78, respectively. An average of 1.43 sigma metrics was determined. In particular, only positive biases for ABVD-16 and 17 were shown in the liquid chromatography tandem-mass spectrometry (LC-MS/MS), which is the standard method for vitamin D determination when compared to the reference values. The causes of the difference can be explained by cross reactivity to various vitamin D metabolites. Laboratories need to improve their overall performance.
Keywords
Liquid chromatography-tandem mass spectrometry; Sigma metrics; Vitamin D;
Citations & Related Records
연도 인용수 순위
  • Reference
1 Lavie CJ, Dinicolantonio JJ, Milani RV, O'Keefe JH. Vitamin D and cardiovascular health. Circulation. 2013;128:2404-2406. http://doi.org/10.1161/CIRCULATIONAHA.113.002902   DOI
2 Holick MF. Sunlight and vitamin D for bone health and prevention of autoimmune diseases, cancers, and cardiovascular disease. Am J Clin Nutr. 2004;80:1678s-1688s. http://doi.org/10.1093/ajcn/80.6.1678S   DOI
3 Mathieu C, Badenhoop K. Vitamin D and type 1 diabetes mellitus: state of the art. Trends Endocrinol Metab, 2005;16:261-266. http://doi.org/10.1016/j.tem.2005.06.004   DOI
4 Dawson-Hughes B, Mithal A, Bonjour JP, Boonen S, Burckhardt P, Fuleihan GE, et al. IOF position statement: vitamin D recommendations for older adults. Osteoporos Int. 2010;21:1151-1154. http://doi.org/10.1007/s00198-010-1285-3   DOI
5 Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, et al. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96:1911-1930. http://doi.org/10.1210/jc.2011-0385   DOI
6 Woloszynska-Read A, Johnson CS, Trump DL. Vitamin D and cancer: clinical aspects. Best Pract Res Clin Endocrinol Metab. 2011;25:605-615. http://doi.org/10.1016/j.beem.2011.06.006   DOI
7 Shimada K, Mitamura K, Higashi T. Gas chromatography and high performance liquid chromatography of natural steroids. J Chromatogr A. 2001;935:141-172. http://doi.org/10.1016/s0021-9673(01)00943-8   DOI
8 Lee J, Vasikaran S. Current recommendations for laboratory testing and use of bone turnover markers in management of osteoporosis. Ann Lab Med. 2012;32:105-112. http://doi.org/10.3343/alm.2012.32.2.105   DOI
9 Binkley N, Krueger D, Cowgill CS, Plum L, Lake E, Hansen KE, et al. Assay variation confounds the diagnosis of hypovitaminosis D: a call for standardization. J Clin Endocrinol Metab. 2004;89: 3152-3157. http://doi.org/10.1210/jc.2003-031979   DOI
10 Roth HJ, Schmidt-Gayk H, Weber H, Niederau C. Accuracy and clinical implications of seven 25-hydroxyvitamin D methods compared with liquid chromatography-tandem mass spectrometry as a reference. Ann Clin Biochem. 2008;45:153-159. http://doi.org/10.1258/acb.2007.007091   DOI
11 Glendenning P, Taranto M, Noble JM, Musk AA, Hammond C, Goldswain PR, et al. Current assays overestimate 25-hydroxyvitamin D3 and underestimate 25-hydroxyvitamin D2 compared with HPLC: need for assay-specific decision limits and metabolite- specific assays. Ann Clin Biochem. 2006;43:23-30. http://doi.org/10.1258/000456306775141650   DOI
12 Westgard JO, editor. Basic method validation. 2nd ed. Madison: Westgard QC Inc.; 2003.
13 Westgard JO, Westgard SA. The quality of laboratory testing today: an assessment of sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. Am J Clin Pathol. 2006;125: 343-354.   DOI
14 Milinkovic N, Ignjatovic S, Sumarac Z, Majkic-Singh N. Uncertainty of measurement in laboratory medicine. J Med Biochem. 2018; 37:279-288. http://doi.org/10.2478/jomb-2018-0002   DOI
15 Chemistry Resource Committee. ABVD Participant Summary [Internet]. Northfield, IL: College of American Pathologists; 2013 [cited by 2020 Feb 19]. Available from: https://www.cap.org/member-resources/councils-committees/accuracy-based-testing-committee-participant-summary-report-discussions
16 Nar R, Emekli DI. The evaluation of analytical performance of immunoassay tests by using six-sigma method. J Med Biochem. 2017;36:301-308. http://doi.org/10.1515/jomb-2017-0026   DOI
17 Erdman P, Palmer-Toy DE, Horowitz G, Hoofnagle A. Accuracybased vitamin D survey: six years of quality improvement guided by proficiency testing. Arch Pathol Lab Med. 2019;143:1531-1538. https://doi.org/10.5858/arpa.2018-0625-CP   DOI
18 Maunsell Z, Wright DJ, Rainbow SJ. Routine isotope-dilution liquid chromatography-tandem mass spectrometry assay for simultaneous measurement of the 25-hydroxy metabolites of vitamins D2 and D3. Clin Chem. 2005;51:1683-1690. http://doi.org/10.1373/ clinchem.2005.052936   DOI
19 Schleicher RL, Encisco SE, Chaudhary-Webb M, Paliakov E, McCoy LF, Pfeiffer CM. Isotope dilution ultra performance liquid chromatography-tandem mass spectrometry method for simultaneous measurement of 25-hydroxyvitamin D2, 25-hydroxyvitamin D3 and 3-epi-25-hydroxyvitamin D3 in human serum. Clin Chim Acta. 2011;412:1594-1599. http://doi.org/10.1016/j.cca.2011.05.010   DOI
20 Chen H, McCoy LF, Schleicher RL, Pfeiffer CM. Measurement of 25-hydroxyvitamin D3 (25OHD3) and 25-hydroxyvitamin D2 (25OHD2) in human serum using liquid chromatography-tandem mass spectrometry and its comparison to a radioimmunoassay method. Clin Chim Acta. 2008;391:6-12. http://doi.org/10.1016/j.cca.2008.01.017   DOI
21 Kushnir MM, Ray JA, Rockwood AL, Roberts WL, La'ulu SL, Whittington JE, et al. Rapid analysis of 25-hydroxyvitamin D(2) and D(3) by liquid chromatography-tandem mass spectrometry and association of vitamin D and parathyroid hormone concentrations in healthy adults. Am J Clin Pathol. 2010;134:148-156. http://doi.org/10.1309/AJCPPIA7DFBT4GKS   DOI
22 Saenger AK, Laha TJ, Bremner DE, Sadrzadeh SM. Quantification of serum 25-hydroxyvitamin D(2) and D(3) using HPLC-tandem mass spectrometry and examination of reference intervals for diagnosis of vitamin D deficiency. Am J Clin Pathol. 2006;125:914-920. http://doi.org/10.1309/J32U-F7GT-QPWN-25AP   DOI
23 Vogeser M. Quantification of circulating 25-hydroxyvitamin D by liquid chromatography-tandem mass spectrometry. J Steroid Biochem Mol Biol. 2010;121:565-573. http://doi.org/10.1016/j.jsbmb.2010.02.025   DOI
24 Lind C, Chen J, Byrjalsen I. Enzyme immunoassay for measuring 25-hydroxyvitamin D3 in serum. Clin Chem. 1997;43:943-949.   DOI
25 Wyness SP, Straseski JA. Performance characteristics of six automated 25‐hydroxyvitamin D assays: Mind your 3s and 2s. Clin Biochem. 2015;48:1089‐1096. https://doi.org/10.1016/j.clinbiochem. 2015.08.005   DOI
26 Hojskov CS, Heickendorff L, Moller HJ. High-throughput liquid-liquid extraction and LCMSMS assay for determination of circulating 25(OH) vitamin D3 and D2 in the routine clinical laboratory. Clin Chim Acta. 2010;411:114-116. http://doi.org/10.1016/j.cca.2009.10.010   DOI
27 Armas LA, Hollis BW, Heaney RP. Vitamin D2 is much less effective than vitamin D3 in humans. J Clin Endocrinol Metab. 2004;89:5387-5391. http://doi.org/10.1210/jc.2004-0360   DOI
28 Houghton LA , Vieth R. The case against ergocalciferol (vitamin D2) as a vitamin supplement. Am J Clin Nutr. 2006;84:694-697. http://doi.org/10.1093/ajcn/84.4.694   DOI
29 Hollis B. Assessment and interpretation of circulating 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D in the clinical environment. Endocrinol Metab Clin North Am. 2010;39:271-287. http://doi.org/10.1016/j.ecl.2010.02.012   DOI
30 Saleh L, Mueller D, von Eckardstein A. Analytical and clinical performance of the new Fujirebio 25‐OH vitamin D assay, a comparison with liquid chromatography‐tandem mass spectrometry (LCMS/ MS) and three other automated assays. Clin Chem Lab Med CCLM FESCC. 2016;54:617‐625. https://doi.org/10.1515/cclm-2015-0427
31 Farrell CJ, Martin S, McWhinney B, Straub I, Williams P, Herrmann M. State-of-the-art vitamin D assays: a comparison of automated immunoassays with liquid chromatography-tandem mass spectrometry methods. Clin Chem. 2012;58:531-542. https://doi.org/10.1373/clinchem.2011.172155   DOI
32 Janssen MJ, Wielders JP, Bekker CC, Boesten LS, Buijs MM, Heijboer AC, et al. Multicenter comparison study of current methods to measure 25-hydroxy-vitamin D in serum. Steroids. 2012;77:1366-1372. https://doi.org/10.1016/j.steroids.2012.07.013   DOI
33 Dawson-Hughes B, Heaney RP, Holick MF, Lips P, Meunier PJ, Vieth R. Estimates of optimal vitamin D status. Osteoporos Int. 2005;16:713-716. http://doi.org/10.1007/s00198-005-1867-7   DOI
34 Audran M, Kumar R. The physiology and pathophysiology of vitamin D. Mayo Clin Proc. 1985;60:851-866. http://doi.org/10.1016/s0025-6196(12)64791-0   DOI
35 Norman AW. From vitamin D to hormone D: fundamentals of the vitamin D endocrine system essential for good health. Am J Clin Nutr. 2008;88:491-499. http://doi.org/10.1093/ajcn/88.2.491S   DOI
36 Holick MF. Vitamin D status: measurement, interpretation and clinical application. Ann Epidemiol. 2009;19:73-78. http://doi.org/10.1016/j.annepidem.2007.12.001   DOI